US government awards Novavax $ 1.6 billion for coronavirus vaccine

US government awards Novavax $ 1.6 billion for coronavirus vaccine

US government awards Novavax $ 1.6 billion for coronavirus vaccine

The U.S. government has allocated $ 1.6 billion to biopharmaceutical company Novavax Inc to test, commercialize, and manufacture a potential coronavirus vaccine in the United States with a target of 100 million doses delivered by January 2021.

This grant is the largest in monetary terms for a public-private partnership project «Operation Warp Speed», initiated by the United States federal government to promote and accelerate the development, production and distribution of COVID-19 vaccines, therapeutics and diagnostics.

«The Warp Speed ​​Bonus is that it pays for the production of 100 million doses that will ship from the beginning of the fourth quarter of this year and could be completed by January or February next year.», – Novavax CEO told Reuters Stanley Erck.

It will also cover the cost of conducting a large-scale Phase III vaccine trial, the final phase of human testing, which could begin as early as October..

This announcement follows a $ 456 million investment to Johnson & Johnson in March, rewarded in $ 486 million for Moderna Inc in April, and about $ 1.2 billion in support in May for the AstraZeneca vaccine, which is being developed jointly with the University of Oxford. The U.S. government has also allocated $ 628 million to Emergent Biosolutions to expand domestic manufacturing capacity to create a potential coronavirus vaccine and drugs to treat COVID-19..

A safe and effective vaccine is considered critical to defeat the virus and end the pandemic that has killed more than half a million people worldwide, about a quarter of whom are US citizens..

The Gaithersburg, Maryland-based company is a dark horse in the race to develop a coronavirus vaccine. The company did not make it to the list of finalists for vaccine developers for the Warp Speed ​​project, which included Moderna, AstraZeneca, Pfizer Inc, J&J and Merck & Co.

In May, Novavax received an additional $ 388 million to fund the development of a COVID-19 vaccine from the Coalition for Epidemic Preparedness Innovation (CEPI), in addition to an investment of $ 4 million in March. In June, the US Department of Defense allocated $ 60 million to the company to support the production of 10 million doses of vaccine in 2020.

According to the CEO, the company is in the process of transferring its technology production of vaccines by an unnamed contract manufacturer, which has two large manufacturing facilities. This is in addition to the work done by Emergent Biosolutions, which produces and supplies companies with doses for small and early clinical trials..

The Novavax vaccine works in combination with an adjuvant, a substance that enhances the immune response and helps the body build up a strong defense against the virus.

Novavax is currently manufacturing an adjuvant in Sweden. The company is ramping up manufacturing capacity in the US for its adjuvant, «so that we can make over a billion doses of adjuvant in the United States», said Stanley Erk.

Novavax did not begin human safety trials until the end of May. One reason for the delay is that the vaccine is grown in insect cells, a process that can take up to 30 days before the company’s scientists can begin purification and mass production..

Erk said Novavax expects results from a phase I trial on vaccine safety within next week. The company plans to start testing the second phase in August or September, and the phase III phase in October..

The company is expected to be able to produce 50 million doses per month in the United States by early next year..

Erk says Novavax also has a manufacturing plant in the Czech Republic and hopes to get two more plants in Europe and one in Asia. The company also works with a manufacturer in India. The goal is to do over 100 million doses a month, he says..

Novavax promotions jumped today at the premarket by more than 30%.